Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Feasibility of interventions as measured by accrual rate |
Feasibility of interventions as measured by accrual rate will be calculated as the number of adolescent and young adult cancer (AYA) survivors who agreed to participate divided by the number of months of recruitment |
at 3 months |
|
| Primary |
Feasibility of interventions as measured by participation rate |
Feasibility of interventions as measured by participation rate will be calculated as the number of participants who agreed to participate divided by the number of eligible AYA survivors. |
at 3 months |
|
| Primary |
Feasibility of interventions as measured by retention rate |
Feasibility of interventions as measured by retention rate will be calculated as the number of AYA survivor participants who completed 3-month measures divided by the number who participated. |
At 3 months |
|
| Secondary |
Retention rate at 6 months |
Retention rate at 6 months, calculated by the number of participants who completed all study measures at the 6-month time point divided by the number who participated. |
At 6 months |
|
| Secondary |
Acceptability of Young Adult Cancers (AYAs) Connect |
Acceptability of the interventions will be measured by ratings of program acceptability and satisfaction. Participants will provide ratings on the helpfulness and difficulty of the program's behavioral goals (e.g., diet and physical activity goals) using an 8-point scale (1 = Not satisfied/Very difficult to 8 = Very satisfied/very easy). Additional questions will ask participants about the helpfulness of intervention features (e.g., lessons, feedback messages) for reaching their weight goals (1 = Not at all helpful to 4 = Extremely helpful). Higher scores indicate greater acceptability. |
At 3 and 6 month |
|
| Secondary |
Adherence to dietary tracking |
Number of days red foods (high-calorie, high-fat foods) are tracked, as measured by the food log data in the AYA Connect app. Participants will be asked to log their red foods in the app daily. |
Up to 6 month |
|
| Secondary |
Adherence to physical activity monitoring |
Number of days physical activity is tracked, as measured by activity tracker |
Up to 6 month |
|
| Secondary |
Adherence to self-weighing |
Number of days weighed, as measured by smart scale |
Up to 6 month |
|
| Secondary |
Change in weight |
Change in weight, as measured by smart scale, from baseline to 3 and 6 months. |
Up to 6 month |
|
| Secondary |
Change in energy intake |
Change in energy intake (kcal), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate energy intake. |
from the baseline to 3 and 6 month |
|
| Secondary |
Change in saturated fat intake |
Change in saturated fat intake (% kcal), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24 The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate saturated fat intake. |
from the baseline to 3 and 6 month |
|
| Secondary |
Change in fruit and vegetable consumption |
Change in fruit and vegetable consumption (cups), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate average fruit and vegetable consumption. |
from the baseline to 3 and 6 month |
|
| Secondary |
Change in fiber consumption |
Change in fiber consumption (g), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate fiber consumption. |
from the baseline to 3 and 6 month |
|
| Secondary |
Change in Healthy Eating Index score |
Change in Healthy Eating Index (HEI) score, measured using the HEI and the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate HEI. HEI scores range from 0 to 100, with higher scores indicating greater adherence to the Dietary Guidelines for Americans. |
from the baseline to 3 and 6 month |
|
| Secondary |
Change in weekly minutes of moderate-to-vigorous activity |
Changes in weekly minutes of moderate-to-vigorous activity, computed from the participant's activity tracker data and averaged over a minimum of 4 out of a 7-day period. Participants will be instructed to wear the activity tracker at all times. |
From baseline to 3 and 6 months |
|
| Secondary |
Change in steps per day |
Changes in daily steps, were computed from the participant's activity tracker data and averaged over a minimum of 4 out of a 7-day period. Participants will be instructed to wear the activity tracker at all times. |
From baseline to 3 and 6 months |
|
| Secondary |
Change in self-reported physical activity |
Change in self-reported physical activity, measured using the Paffenbarger Activity Scale (PAQ). The PAQ provides an estimate of minutes per week of moderate-to-vigorous intensity, and calories/week of light (5 kcal/min), medium (7.5 kcal/min), and high (10 kcal/min) intensity activities. PAQ changes have been predictive of weight change. |
From baseline to 3 and 6 months |
|
| Secondary |
Change in frailty index |
Change in frailty index, measured using the FRAIL Questionnaire. The FRAIL Questionnaire assesses: 1) self-reported fatigue (1 item from Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health), 2) weight loss, 3) comorbidities (11 items from UNC Health Registry Comorbidity Assessment), 4) difficulty with ambulation (1 item from PROMIS Global Health), and 5) ability to overcome resistance (1 item from Medical Outcomes Study 36-Item Short Form). Positive responses for these components are summed to create the FRAIL index (range 0-5). A value > 3 is considered frail, and a value of 2 is considered prefrail. |
From baseline to 3 and 6 months |
|
| Secondary |
Change in health-related quality of life |
Change in health-related quality of life, measured using the Medical Outcomes Study 36-Item Short Form (SF-36) survey. This survey includes 36 items with eight subscales (physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions). Responses are coded on a scale of 0 to 100, where 0 is the worst possible health and 100 is the most favorable health score. The coded responses will be summed to yield a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. |
From baseline to 3 and 6 months |
|
| Secondary |
Change in depressive symptoms |
Change in depressive symptoms, measured by the Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a self-report depression scale including 20 items that relate to depressive feelings and behaviors during the past week. Response options range from 0 (rarely or none of the time) to 3 (most or almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. |
From baseline to 3 and 6 months |
|
| Secondary |
Change in anxiety symptoms |
Change in anxiety symptoms, as measured using the Generalized Anxiety Disorder 7-item scale (GAD-7). Possible scores range from 0 to 21, with higher scores reflecting greater symptom severity; cut-points of 5, 10, and 15 correspond to mild, moderate, and severe levels of anxiety. |
From baseline to 3 and 6 months |
|
| Secondary |
Change in perceived stress |
Change in perceived stress, measured by the 10-item Perceived Stress Scale (PSS-10). PSS-10 measures overall perceived stress during the past month. Factor analysis supports a two-factor correlated model with perceived self-efficacy and perceived helplessness subscales. |
From baseline to 3 and 6 months |
|
| Secondary |
Change in positive and negative affect |
Change in positive and negative affect, measured using the Positive and Negative Affect Schedule (PANAS). PANAS is a 20-item scale divided into two subscales to measure positive and negative affect. Each item is rated on a five-point Likert scale from 1 (very slightly or not at all) to 5 (extremely) and are summed to yield scores for each subscale. |
From baseline to 3 and 6 months |
|
